Drug recall
Enbrel (etanercept) SureClick Autoinjector, 50 mg/mL, For Subcutaneous Use Only, Rx only, Manufactured by…
FDA recall event 53380 · Class II · Amgen Manufacturing, Limited
Key facts
| Event ID | 53380 |
|---|---|
| Recall numbers | D-327-2010 |
| Recalling firm | Amgen Manufacturing, Limited |
| Product type | Drugs |
| Products | Enbrel (etanercept) SureClick Autoinjector, 50 mg/mL, For Subcutaneous Use Only, Rx only, Manufactured by Immunex Corporation, Thousand Oaks, CA, Marketed by Amgen and Wyeth Pharmaceuticals, NDC… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Lack of Assurance of Sterility: Syringe barrel flange that slightly deviated from the center line of the syringe barrel, resulted in broken or cracked syringes |
| Initiation date | Sep 9, 2009 |
| Termination date | Feb 23, 2012 |
| City | Juncos |
| State | PR |
| Country | United States |
| FEI number | 1000110364 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports